Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients
Flo 24
1 other identifier
interventional
26
4 countries
10
Brief Summary
The purpose of this study is to assess the safety and feasibility of the NeuroFlo™ catheter in treating patients with ischemic stroke whose last time symptom-free was between 8-24 hours prior to treatment. The NeuroFlo device is intended to increase blood flow to the brain and potentially reduce the damage caused by stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2007
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 16, 2007
CompletedFirst Posted
Study publicly available on registry
February 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedFebruary 5, 2009
February 1, 2009
1.9 years
February 16, 2007
February 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of all adverse events from baseline to 30 days post-treatment.
30 Days
Secondary Outcomes (2)
Potential benefit will be assessed through collection of neurological indices at baseline, post-procedure, 24 hours, day 4 (or discharge), 30 and 90 days.
90 Days
Cerebral perfusion changes associated with device therapy will be assessed using MRI perfusion studies acquired at baseline and ≤ 4 hours post-procedure.
≤ 4 hours
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Ischemic stroke
- NIHSS between 4-20
- Time from symptom onset between 8 and 24 hours
You may not qualify if:
- Hemorrhagic stroke
- Certain types of heart disease
- Kidney disease
- Other conditions the doctor will assess
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CoAxialead
Study Sites (10)
UCLA
Los Angeles, California, 90024, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Rochester
Rochester, New York, 14642, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
University of Calgary
Calgary, Alberta, T2N 2T9, Canada
University of Alberta
Edmonton, Alberta, T6G 2B7, Canada
University of Erlangen
Erlangen, Germany
University of Essen
Essen, Germany
CHUV Lausanne
Lausanne, Switzerland
Related Publications (1)
Hammer MD, Schwamm L, Starkman S, Schellinger PD, Jovin T, Nogueira R, Burgin WS, Sen S, Diener HC, Watson T, Michel P, Shuaib A, Dillon W, Liebeskind DS. Safety and feasibility of NeuroFlo use in eight- to 24-hour ischemic stroke patients. Int J Stroke. 2012 Dec;7(8):655-61. doi: 10.1111/j.1747-4949.2011.00719.x. Epub 2012 Jan 20.
PMID: 22264202DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Flo 24 Steering Committee
Multiple Organizations
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 16, 2007
First Posted
February 19, 2007
Study Start
February 1, 2007
Primary Completion
January 1, 2009
Study Completion
January 1, 2009
Last Updated
February 5, 2009
Record last verified: 2009-02